A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis

Phase 2

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: UHE-103A2B cream; Drug: UHE-103A1 cream; Drug: UHE-103A2 cream; Drug: UHE-103B cream; Drug: UHE-103A1B cream

• Registration Number: NCT03897257
• Lead Sponsor: Therapeutics, Inc.

Brief Summary

The study is being done to determine and compare the safety and effectiveness of an investigational combination therapy (low and high concentrations) versus mono-therapy (low and high concentrations) or mono-therapy (fixed concentration) in subjects with moccasin type tinea pedis.

Detailed Description

UHE-103 cream is an investigational combination drug to treat moccasin type tinea pedis, a fungal infection that affects the feet and toes. Eligible subjects will be assigned to one of the 5 possible treatment groups and participate for a total of 6 weeks. Subjects will apply their assigned test drug twice daily for 2 weeks. Each subject will then be assessed for safety and efficacy at week 4 and week 6. There will be a total of 5 clinic visits: 1 screening/baseline visit (Day 1), 2 treatment visits (Days 8 and 15), and 2 follow-up visits (Days 29 and 43).

Study Timeline

• Study Start: 2019-03-15
• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Primary Completion: 2019-10-21
• Study Completion: 2020-05-05
• Disposition First Submitted: 2020-06-09
• Status Verified: 2021-10
• Disposition First Submitted QC: 2021-10-26
• Last Update Submitted: 2021-10-26
• Disposition First Posted: 2021-10-28
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Male or non-pregnant female, 16 years of age or older.
• Clinical diagnosis of moccasin type tinea pedis
• Microscopic evidence (positive KOH) of the presence of fungi
• Provided written informed consent/assent
• In general good health

Exclusion Criteria

• Pregnant or lactating or planning to get pregnant while on the study
• Has concurrent tinea infection (e.g., tinea versicolor, tinea cruris)
• Other skin disease which might interfere with the evaluation of tinea pedis
• History of diabetes mellitus or is immunocompromised
• Currently enrolled in an investigational drug or device study
• Used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Study Day 1)/Baseline

Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UHE-103A2B cream	UHE-103A2B cream	Topical cream applied twice daily for 2 weeks.
UHE-103A1 cream	UHE-103A1 cream	Topical cream applied twice daily for 2 weeks.
UHE-103A2 cream	UHE-103A2 cream	Topical cream applied twice daily for 2 weeks.
UHE-103B cream	UHE-103B cream	Topical cream applied twice daily for 2 weeks.
UHE-103A1B cream	UHE-103A1B cream	Topical cream applied twice daily for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Complete Cure at End of Study	Day 43	Proportion of subjects with Complete Cure (negative fungal test \& no clinical disease-induced signs and symptoms) at end of study (EOS).

Secondary Outcome Measures

Name	Time	Method
Effective treatment	Day 43	Proportion of subjects with Effective Treatment (negative fungal test \& no to mild clinical disease-induced signs and symptoms) at EOS.
Mycological Cure	Day 43	Proportion of subjects with Mycological Cure (negative fungal test) at EOS.

Trial Locations

Locations (12)

Site 08; 🇵🇷 Cidra, Puerto Rico

Site 02; 🇺🇸 Houston, Texas, United States

Site 12; 🇺🇸 Melbourne, Florida, United States

Site 03; 🇺🇸 San Diego, California, United States

Site 09; 🇺🇸 North Miami Beach, Florida, United States

Site 06; 🇺🇸 Miami, Florida, United States

Site 05; 🇺🇸 Norfolk, Virginia, United States

Site 11; 🇺🇸 Fridley, Minnesota, United States

Site 01; 🇺🇸 Austin, Texas, United States

Site 07; 🇺🇸 Rolling Meadows, Illinois, United States

Site 04; 🇺🇸 Rochester, New York, United States

Site 10; 🇺🇸 San Antonio, Texas, United States